MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-07-02 for ACCESS 2 IMMUNOASSAY ANALYZER 81600N manufactured by Beckman Coulter.
[6540289]
The customer reported obtaining multiple erroneous thyroglobulin antibody (access thyroglobulin antibody ii) and thyroglobulin (access thyroglobulin) results for two (2) patients on the laboratory's access 2 immunoassay system (serial number (b)(4)). The customer reanalyzed the patient's samples on the laboratory's alternate access 2 immunoassay system (serial number (b)(4)) and obtained lower results, both within the same clinical category and in different clinical categories. Initial results were reported out of the laboratory and were questioned by the physician. The samples were reanalyzed and corrected reports were sent out. The customer was unaware of change to patient treatment associated with this event. Mdr 2122870-2015-00378 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for three (3) patients. Mdr 2122870-2015-00391 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for two (2) patients. Mdr 2122870-2015-00392 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for four (4) patients. Mdr 2122870-2015-00394 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for one (1) patient. Mdr 2122870-2015-00395 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for five (5) patients. Mdr 2122870-2015-00396 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for two (2) patients. Mdr 2122870-2015-00397 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for five (5) patients. Mdr 2122870-2015-00398 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for four (4) patients. Mdr 2122870-2015-00399 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for three (3) patients. Mdr 2122870-2015-00400 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for one (1) patient. Mdr 2122870-2015-00401 will address the access thyroglobulin antibody ii results obtained on (b)(6)2015 for one (1) patient. Mdr 2122870-2015-00402 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for one (1) patient. Mdr 2122870-2015-00403 will address the access thyroglobulin antibody ii and access thyroglobulin results obtained on (b)(6) 2015 for eight (8) patients. Qc (quality controls), calibrations and system checks were all performing within assay and instrument specifications prior to june 3, 2015. On june 3, 2015 system check failed to meet specifications and a precision test for the access thyroglobulin antibody ii failed as all results were zero (0). The patient samples were drawn in serum tubes with and without gel separators. The samples are either drawn in-house or sent from another facility. The in-house samples are centrifuged at 3,500 revolutions per minute (rpm) at room temperature for five (5) minutes. No issue with sample integrity was reported by the customer. A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer.
Patient Sequence No: 1, Text Type: D, B5
[14148961]
The customer did not provide patient demographics such as age, sex, date of birth or weight. A beckman coulter (bec) field service engineer (fse) was dispatched to assess the analyzer. The fse discovered foaming in the wash pump during the dispense probes prime cycle. The fse determined the foaming was due to a faulty wash valve rotor. The fse observed wear on the rotor shaft key which was causing foaming at the supply position. The rotor was replaced. After the repairs were completed, the fse performed hardware and system verification tests which passed within published performance specifications. In conclusion, the wash valve rotor was determined to be the cause of this event. All associated mdrs for this event: mdr 2122870-2015-00378, mdr 2122870-2015-00391, mdr 2122870-2015-00392, mdr 2122870-2015-00393, mdr 2122870-2015-00394, mdr 2122870-2015-00395, mdr 2122870-2015-00396, mdr 2122870-2015-00397, mdr 2122870-2015-00398, mdr 2122870-2015-00399, mdr 2122870-2015-00400, mdr 2122870-2015-00401, mdr 2122870-2015-00402, mdr 2122870-2015-00403. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2122870-2015-00393 |
| MDR Report Key | 4887696 |
| Report Source | 05,06 |
| Date Received | 2015-07-02 |
| Date of Report | 2015-06-03 |
| Date of Event | 2015-05-23 |
| Date Mfgr Received | 2015-06-03 |
| Device Manufacturer Date | 2012-07-18 |
| Date Added to Maude | 2015-07-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFFREY KOLL |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal | 55318 |
| Manufacturer Phone | 9523681361 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 1000 LAKE HAZELTINE DRIVE |
| Manufacturer City | CHASKA 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESS 2 IMMUNOASSAY ANALYZER |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE, PRODUCT CODE: JJE |
| Product Code | JNL |
| Date Received | 2015-07-02 |
| Model Number | NA |
| Catalog Number | 81600N |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 1000 LAKE HAZELTINE DRIVE CHASKA 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-02 |